Success Metrics

Clinical Success Rate
100.0%

Based on 3 completed trials

Completion Rate
100%(3/3)
Active Trials
7(50%)
Results Posted
100%(3 trials)

Phase Distribution

Ph phase_1
3
21%
Ph phase_2
3
21%
Ph phase_3
7
50%
Ph phase_4
1
7%

Phase Distribution

3

Early Stage

3

Mid Stage

8

Late Stage

Phase Distribution14 total trials
Phase 1Safety & dosage
3(21.4%)
Phase 2Efficacy & side effects
3(21.4%)
Phase 3Large-scale testing
7(50.0%)
Phase 4Post-market surveillance
1(7.1%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

100.0%

3 of 3 finished

Non-Completion Rate

0.0%

0 ended early

Currently Active

7

trials recruiting

Total Trials

14

all time

Status Distribution
Active(11)
Completed(3)

Detailed Status

Active, not recruiting6
Completed3
Not yet recruiting3
Enrolling by invitation1
Recruiting1

Development Timeline

Analytics

Development Status

Total Trials
14
Active
7
Success Rate
100.0%
Most Advanced
Phase 4

Trials by Phase

Phase 13 (21.4%)
Phase 23 (21.4%)
Phase 37 (50.0%)
Phase 41 (7.1%)

Trials by Status

enrolling_by_invitation17%
completed321%
active_not_recruiting643%
not_yet_recruiting321%
recruiting17%

Recent Activity

Clinical Trials (14)

Showing 14 of 14 trials
NCT04610866Phase 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Active Not Recruiting
NCT04770753Phase 3

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

Active Not Recruiting
NCT05175105Phase 3

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

Active Not Recruiting
NCT05144256Phase 3

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

Active Not Recruiting
NCT04770779Phase 3

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

Active Not Recruiting
NCT05031780Phase 2

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

Active Not Recruiting
NCT07506863Phase 3

A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

Not Yet Recruiting
NCT07517133Phase 3

A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia

Not Yet Recruiting
NCT05777993Phase 4

A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study

Enrolling By Invitation
NCT06286046Phase 2

A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy

Not Yet Recruiting
NCT03853798Phase 3

Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007

Completed
NCT07055243Phase 2

To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII.

Recruiting
NCT06648824Phase 1

Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

Completed
NCT05610657Phase 1

A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function

Completed

All 14 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
14